Prospective randomized comparison of endoscopic ultrasound-guided radiofrequency ablation (RFA) and mFOLFIRINOX parallel therapy and chemotherapy monotherapy in patients with pancreatic cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0007349
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 92
1. An adult between the ages of 20 and under the age of 80 who can understand the clinical trial and who voluntarily agrees to participate in the trial and who can sign a written consent form.
2. Patients who have been confirmed for pancreatic cancer using biopsy
3. Estimated life expectancy of 6 months or more
4. Patients with locally advanced pancreatic cancer according to NCCN criteria (determined by CT, MRI, or PET-CT results)
5. If EUS-RFA is available at the time of screening (as determined by the gastroenterologist)
6. There is no uncontrolled active infection, except for chronic viral hepatitis under antiviral treatment.
7. Eastern Oncology Joint Research Group (ECOG) performance status is 0 or 1
8. Weight > 30 kg
9. Normal organ and bone marrow function
10. The subject has the will and ability to comply with the clinical trial plan during the trial period, including follow-up and receiving dosing and scheduled visits and tests.
11. In the absence of any other malignant disease, except for non-melanoma skin cancer, cervical epithelial carcinoma, localized prostate cancer or thyroid papillary cancer, or all other cancers previously treated for healing purposes for more than 5 years without evidence of recurrence;
1. If there is an internal or psychiatric condition that threatens the subject's ability to provide consent or comply with the clinical trial plan, or if there is a history of non-adherence;
2. When the gastrointestinal tract is closed
3. If you have a myocardial infarction within 6 months prior to administration of the test drug and have other clinically significant heart disease (e.g., unstable angina, congestive heart failure or uncontrolled high blood pressure)
4. If, in the opinion of the examiner, there is evidence of a severe or uncontrolled systemic disease or co-occurrence that makes it undesirable for the test subject to participate in the trial or jeopardizes compliance with the clinical trial plan;
5. Adenocarcinoma/squamous complex, neuroendocrinoma
6. If you have a history of allogeneic organ transplantation
7. If you have a history of other primary malignant tumors except the following:
a. Malignant tumors that have been treated for healing purposes and have no known active disease for more than 5 years prior to the first dose of IP, and have a low potential risk of recurrence
b. Disease unfounded and properly treated non-melanoma skin cancer or malignant sunspots
c. Endothelial carcinoma that has no basis for the disease and has been properly treated
8. Pregnant or breastfeeding female test subjects, or childbearing men or women who are not willing to use effective contraceptive methods from screening until 90 days after the last dose of chemotherapy after surgery.
9. If an allergy or hypersensitivity is known to any of the test drugs or to any of the test drug additives
10. If the tester determines that the test subject is not suitable to participate in the test and that the test subject is unlikely to comply with the test procedures, restrictions and requirements
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1yr progression free survival, PFS
- Secondary Outcome Measures
Name Time Method overall survival, OS; progression free survival, PFS; RECIST v1.1; R0, R1; NCI-CTCAE v5.0